To compare the efficacy, programming burden, power consumption, and physicians' and patients' satisfaction between current mode and voltage mode of deep brain stimulation in each period one year after surgery.
Patients with idiopathic Parkinson's disease
Aged 18 to 75, no limited sex
After bilateral STN-DBS, yet not powered on
Mental disorders or dementia
Pregnant, lactating women or women who are unable to take effective measures to prevent pregnancy
Serious health conditions, such as tumors, liver or kidney diseases, etc.
Epilepsy or other seizure disorders
Parallel
Constant current (CC) subthalamic nucleus deep brain stimulation
Other interventionFor subjects who have decided to undergo STN-DBS surgery and meet the inclusion criteria, the constant current (CC) mode is selected as the original electronic modality one week after surgery. Regardless of any changes in programming parameters over the following year, the constant current (CC) mode will be maintained.
Constant voltage (CV) subthalamic nucleus deep brain stimulation
Other interventionFor subjects who have decided to undergo STN-DBS surgery and meet the inclusion criteria, the constant voltage (CV) mode is selected as the original electronic modality one week after surgery. Regardless of any changes in programming parameters over the following year, the constant voltage (CV) mode will be maintained.
The change rate of MDS-UPDRS III
MDS-UPDRS III is the motor examination section of the MDS-UPDRS (Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale), completed by the evaluator, providing an objective assessment of motor symptoms in patients with Parkinson's disease. MDS-UPDRS III ranges from 0-132. The change rate of MDS-UPDRS III in the Stim-On/Med-On state from baseline to 6 months after surgery will be collected. Positive indicates improvement.
MDS-UPDRS I
MDS-UPDRS I is the non-motor experiences of daily living section of the MDS-UPDRS (Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale). Subsection IA is evaluated by the researcher based on all relevant information provided by the patient or their caregiver regarding certain symptoms. Subsection IB is completed by the patient, with assistance from the caregiver if needed, but it must not be completed by the researcher. The change rate of MDS-UPDRS I from baseline to 6 months after surgery will be collected.
MDS-UPDRS II
MDS-UPDRS II is the motor experiences of daily living section of the MDS-UPDRS (Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale) and is a self-reported questionnaire completed by the patient. The change rate of MDS-UPDRS II from baseline to 6 months after surgery will be collected.
MDS-UPDRS IV
MDS-UPDRS IV is the motor complications section of the MDS-UPDRS (Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale). This section is rated by the evaluator, combining information provided by the patient with the evaluator's clinical observation and judgment to generate a comprehensive score. The change rate of MDS-UPDRS IV from baseline to 6 months after surgery will be collected.
Clinical Global Impression (CGI)
The Clinical Global Impression (CGI) is a global assessment scale initially designed by the World Health Organization (WHO) for use in IPSS research to evaluate clinical efficacy. It provides an overall measure of treatment outcomes.
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Xuanwu Hospital, Beijing
Lead sponsor
Beijing Pins Medical Co., Ltd
Collaborator
Chinese PLA General Hospital
Collaborator
Tianjin Huanhu Hospital
Collaborator
Kunming Sanbo Brain Hospital
Collaborator
Xijing Hospital
Collaborator
The First People's Hospital of Changde City
Collaborator
The General Hospital of Southern Theater Command
Collaborator
The First Affilated Hospital of the Medical College, Shihezi University
Collaborator
RenJi Hospital
Collaborator
Changshu Hospital of Traditional Chinese Medicine
Collaborator
Hainan General Hospital
Collaborator
Affiliated Hospital of North Sichuan Medical College
Collaborator
Second Affiliated Hospital of Bengbu Medical College
Collaborator
